Panels › General, Plastic Surgery › Product code LRO · Class 2
General Surgery Tray
Regulation 878.4370
0510(k)s in 12 months (110 all time)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Customed, Inc Laparotomy Pack, Catalog number 900-176.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Urology Pack, Catalog number 900-1742.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Urology Pack, Catalog number 900-1738.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Minor Laparotomy Pack, Catalog number 900-1735.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Universal Pack, Catalog number 900-1587.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Dressing Change, Catalog number 900-1538.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Urology Pack, Catalog number 900-1521.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Laparotomy Pack, Catalog number 900-149.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Reyito Urological Pack, Catalog number 900-1460.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Plastic Surgery Pack, Catalog number 900-1402.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Pediatric Lap Pack, Catalog number 900-1383
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Premium Laparotomy Pack, Catalog number 900-1296.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Cysto Tur Pack, Catalog number 900-080.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Major Laparotomy Pack, Catalog number 900-036.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Wound Management Tray, Catalog number 900-1903.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Minor Laceration Tray, Catalog number 900-1765.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Gown Surgical Non Reinforced XL, Catalog number 900-1579.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Wound Management Tray II, Catalog number 900-1198.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Wound Management Tray, Catalog number 900-1154.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Incision & Drainage Tray, Catalog number 900-774.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Dec 16, 2014 | Customed, Inc Universal Drainage Tray, Catalog number 900-032.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Lithotomy Pack III (3), code 900-2487, contains:
(3) TOWEL ABSORBENT 15" X 20"
(1) GOWN LARGE STANDARD SMS VELCRO NECK
(2) LEGGINS WITH 7" CUFF 30" X 42"
(1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35"
(1 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Breast pack TPSC, code 900-3431, contains:
(1) GOWN LARGE STANDARD SMS AAMIIII
(1) GOWN SOFT SMS STD. X-LARGE AAMIIII
(4) TOWELS ABSORBENT 15" X 20" LIF
(1) PENCIL CAUTERY PUSH BOTTOM LIF
(1) SYRINGE Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Gown Impervious , Code 900-3190, contains:
GOWN IMPERVIOUS EXTRA LONG X-LARGE
WITH TOWEL & WRAP
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Breast Pack- FJG, code 900-3118, contains:
(2) GOWN LARGE STANDARD SMS AAMIIII
(2) TOWEL ABSORBENT 15" X 20"
(1) PENCIL CAUTERY PUSH BOTTOM
(1) SYRINGE BULB 60CC
(1) TUBE SUCTION CONNECT~" X 12'
(1) C Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Face Pack FJG, code 900-3116, contains:
(2) GOWN LARGE STANDARD SMS AAMIIII
(2) TOWEL ABSORBENT 15" X 20"
(1) COUNTER NEEDLE & BLADE 20C FOAM/MAG
(1) COVER MAYO STAND REINFORCED
(1) SHEET ENT SPLIT 11 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Liposuction Pack FJG, code 900-3115, contains:
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF
(2) TOWEL ABSORBENT 15" X 20" LIF
(1) NEEDLE HYPODERMIC 25 X 1 LIF
(1) BOWL UTILITY QUART 32oz LIF
( Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Tummy Tuck Pack- FJG, code 900-3114, contains:
(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill
(2) TOWEL ABSORBENT 15" X 20"
(1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER
(1) NEEDLE HYPODERMIC 22G X 1 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc General Cosmetic Pack FCSC, Code 900-3113, contains:
(1) COVER MAYO STAND REINFORCED LIF
(10) LAP SPONGE PREWASH 18" X 18" XRD LIF
(2) GOWN LARGE STANDARD SMS AAMIIII
(1) TABLE COVER REINFORCED 50" X Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Face Lift , Code 900-3083, contains:
(I) SHEET ENT SPLIT 110" X 77" LIF
(I) COVER TABLE REINFORCED 50" X 90" LIF
(I) DRAPE HEAD WITH TAPE 44" X 26" LIF
(I) COVER MAYO STAND REINFORCED LIF
(I) BAG SUTU Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Breast Pack BOD, code 900-3029, contains:
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill
(2) TOWEL ABSORBENT 15" X 20"
(1) PENCIL CAUTERY PUSH BOTTOM
(1) SYRINGE BULB 60CC
(1) TUBE SUCTION CONNEC Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Liposuction Pack BOD, code 900-3028, contains:
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(2) LITE GLOVES LIF
(2) TOWEL ABSORBENT 15" X 20" L/F
(1) NEEDLE HYPODERMIC 27G X 1 %" LIF
(1) BOWL UTILIT Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Face Pack- BOD, code 900-3027, contains:
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(2) TOWELS ABSORBENT 15" X 20"
(1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16"
(1 ) TRAY HALF DEEP
(1) COUNTER NEEDLE/B Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Tummy Tuck Pack-BOD , code 900-3026, contains:
(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII
(2) TOWELS ABSORBENT 15 X 20
(1) PENCIL CAUTERY PUSH BOTTOM
(1) COUNTER NEEDLE/BLADE 20C FOAM/MAG
(1) Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Chole Cystectomy All Endo System , code 900-3025, contains:
(1) TABLE COVER 44X 90 UF
(1) SYRINGE 20ccW/O NDL LUER LOCK LIF
(2) MAYO STAND COVER REINFORCED UF
(1) NEEDLE HYPODERMIC
(6) ABSORBENT TO Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Basic Pack FPSC Florham Pack , code 900-2969, contains:
(1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD
(1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Il Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Hair Restoration Pack- , code 900-2966, contains:
(1) MAYO STAND COVER 23X54
(2) TOWEL CLOTH HUCK BLUE
(2) TABLE COVER BACK ZONE REINFORCED 44 X 90
(2) GOWN SOFT SMS STD. X-LARGE AAMI Ill
(2) TOWEL AB Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc BASIC COSMETIC SURG. PACK
CUSTOMED (USA), CODE 900-2915.
CONTENTS:
(2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F
(1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION C Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc CYSTO TUR PACK BASIC
CODE 900-2899.
CONTENTS:
(2) LEGGINGS W/7'' CUFF 30" X 42"
(1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20"
(1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Il Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK BASIC
CODE 900-2829
CONTENTS:
(2) TOWELS ABSORBENT 15" X 20"
(1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE
(1) BAG SUTURE FLORAL
(1) DRAPE T LAPAROT 102" X 78" X 121" ST Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc REEMPLAZO DE RODILLA Y CADERA
CONTENTS:
(6) TOWELS ABSORBENT 15" X 20"
(I) PK. STRIP STERICLOSURE Y," X 4"
(I) COVER MAYO STAND RErNFORCED
(I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER
(I) BAG Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains:
(1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE
(1) TOWEL ABSORBENT 15" X 20"
(1) WRAPPER 24" X 24"
Product Usage:
EO sterilized surgical co Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Bandeja para Debridacion, code 900-2702, contains:
(1) FORCEP ADSON TISS
(20) GAUZE SPONGES 4 X 4 12PL Y
(1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP
(1) TOWEL 3 PLY POLY 13 X 18
(1) DRAPE 18 X 26 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Tummy Tuck Pack, code 900-2684, contains:
(3) GOWN SOFT SMS STD XLGE SET IN SLEEVE
( 1) CAUTERY PENCIL PUSH BOTTOM
( 1) TUBE SUCTION CONNECT
( 1) MAYO STAND COVER REINFORCED
( 1) SKIN MARKER INK W LAB Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682:
(3) GOWN SOFT SMS STD XLGE SET IN SLEEVE
( 1) CAUTERY PENCIL PUSH BOTTOM
( 1) TUBE SUCTION CONNECT
( 1) MAYO STAND COVER REINFORCED
( 1) SK Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Liposuction Pack, code 900-2681, contains:
(3) GOWN SOFT SMS STD XLGE SET IN SLEEVE
(1) TUBE SUCTION CONNECT
(1) MAYO STAND COVER REINFORCED
(1) SKIN MARKER INK W LABEL
(2) TABLE COVER REINFORCED 50 X Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Tummy Tuck and Liposuction Pack, code 900-2661, contains:
( 1) DRAPE % ECONOMY 53 X 77
(3) GOWN SOFT SMS STANDARD X-LARGE SET IN SLEEVE
(3) TOWELS ABSORBENT 15 X 20
(1) MAYO STAND COVER REINFORCED
(1) Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Breast Implant Pack, Code 900-2660, contains:
(1) DRAPE ECONOMY 53 X 77
(3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE
(3) TOWELS ABSORBENT 15 X 20
(1) MAYO STAND COVER REINFORCED
(2) TABLE COVER REIN Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Breast Pack MRT, code 900-2658, contains:
( 1) BULB SYRINGE 60cc
(2) GOWN SOFT SMS STD XLGE SET IN SLEEVE
( 1) CAUTERY PENCIL PUSH BOTTOM
(2) SYRINGE 10cc W/0 NEEDLE LUER LOCK
( 1) NEEDLE and BLADE CO Terminated |
LRO | None listed |
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